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FDA 510(k)

Rochal Antimicrobial Wound Gel

K-Number: K192527 · 2020-02-07

ApplicantRochal Industries, LLC
Decision Date2020-02-07
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Rochal Antimicrobial Wound Gel is the device name listed in this FDA 510(k) record. The listed applicant is Rochal Industries, LLC. It received FDA 510(k) clearance on 2020-02-07 under 510(k) number K192527. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rochal Antimicrobial Wound Gel?

Rochal Antimicrobial Wound Gel is a medical device that received FDA 510(k) clearance on 2020-02-07. The listed applicant is Rochal Industries, LLC. The 510(k) number is K192527.

When did Rochal Antimicrobial Wound Gel receive FDA 510(k) clearance?

Rochal Antimicrobial Wound Gel received FDA 510(k) clearance on 2020-02-07, under 510(k) number K192527.

Who is the listed applicant for Rochal Antimicrobial Wound Gel?

The FDA 510(k) record lists Rochal Industries, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rochal Antimicrobial Wound Gel?

The FDA product code for Rochal Antimicrobial Wound Gel is FRO. This falls under the Anesthesiology category.

Other records listing Rochal Industries, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182733Rochal Bioshield Silicone FilmK161212Atteris Antimicrobial Skin ProtectantK160192Atteris Antimicrobial Skin & Wound CleanserK160684Atteris No-Sting Skin Protectant

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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